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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K953823
Device Name ARTERIAL VENOUS BLOOD TUBING SET
Applicant
Medisystems Corp.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact SUZAN ONEL
Correspondent
Medisystems Corp.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact SUZAN ONEL
Regulation Number876.5820
Classification Product Code
FJK  
Date Received08/15/1995
Decision Date 09/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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